BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITY NT I-CVR/HFO 541

    MDR report key: 2963258 · Received February 15, 2013

    Report

    Report Number
    2184009-2013-00005
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 20, 2013
    Report Date
    January 21, 2013
    Manufacturer
    PERFUSION SYSTEMS
    Product Code
    DTZ
    PMA / PMN Number
    K973760
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS: UPON RECEIPT AT MEDTRONIC'S QUALITY LABORATORY, VISUAL INSPECTION SHOWED NO OUTWARD SIGNS OF CRACKS OR DAMAGE THROUGHOUT DEVICE OR PORTS. PERFORMANCE ANALYSIS: BLOOD SIDE PRESSURE INTEGRITY TESTING WAS PERFORMED AT THREE LITERS PER MINUTE WITH TWENTY-THREE PSIG OF BACK PRESSURE FOR TEN MINUTES. DURING THE TEST A LEAK FROM THE HEX (HEAT EXCHANGER) SIDE SEAM WAS OBSERVED. THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS PRODUCT MET ALL MANUFACTURING SPECIFICATION FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. CONCLUSION: BASED ON ANALYSIS AND INVESTIGATION, THE LEAK WAS CONFIRMED TO ORIGINATE FROM THE HEX SIDE SEAM. A PARTIAL VOID MAY HAVE FORMED DURING ADHESIVE DISPENSING INTO THE ADHESIVE GROOVE OF THE HEAT EXCHANGER, ALLOWING FOR ACCEPTABLE PRESSURE TEST RESULTS PRIOR TO DISTRIBUTION. IT IS POSSIBLE A PHYSICAL SHOCK ENCOUNTERED DURING SHIPPING OR HANDLING OF THE PRODUCT MAY HAVE COMPROMISED THAT BOND. HISTORICALLY, IT HAS BEEN OBSERVED THAT OVERLY AGGRESSIVE SHIPPING AND HANDLING CAN CAUSE THE PARTIAL BOND TO BECOME COMPROMISED, RESULTING IN A LEAK AND CONTRIBUTING TO THE EVENT. (B)(4).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION INDICATING THAT DURING USE, THIS OXYGENATOR HAD A WATER LEAK FROM THE BOTTOM OF THE HEAT EXCHANGER. THE DEVICE WAS CHANGED OUT WITH NO ADVERSE PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68368 AFFINITY NT I-CVR/HFO 541 OXYGENATOR, CARDIOPULMONARY BYPASS DTZ PERFUSION SYSTEMS 95214 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1